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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/12/803|
|INN :||Concentrate of proteolytic enzymes enriched in bromelain|
|Orphan status based on designation EU/3/02/107 added on 20/12/2012|
|Indication:||NexoBrid is indicated for removal of eschar in adults with deep partial- and full-thickness thermal burns.|
|Marketing Authorisation Holder:||MediWound Germany GmbH
Eisenstr. 5, D-65428 Ruesselsheim, Deutschland
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".|
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|20/12/2012||Centralised - Authorisation||EMEA/H/C/2246||(2012)9858 of 18/12/2012|
|23/09/2013||Centralised - Transfer Marketing Authorisation Holder||EMEA/H/C/2246/T/2||(2013)6218 of 19/09/2013|
|29/10/2013||Centralised - Variation||EMEA/H/C/2246/IA/4/G|